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Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)

Recruiting

This long-term study will help researchers learn more about biomarkerssubstances in human blood and tissuesand their relationship to aging. The goal is to find ways to improve quality of life in old age.

Minimum Age Maximum Age Gender Healthy Volunteers
20 Years 105 Years Both Yes
March 15, 2015
December 31, 2099
300

  • Consent to genetic testing and storage at the screening visit and all subsequent visits
  • Willingness to return every 2 years for study visit procedures
  • Good venous access for cytapheresis
  • Eligible for apheresis, a technology in which one's blood is passed through an apparatus that separates one particular constituent and returns the rest to circulation
  • Weight of 110 pounds or greater and a body mass index of less than 30
  • Ability to care for self without assistance
  • Ability to walk for at least 400 meters without assistance and to perform normal activities of daily living without shortness of breath or other severe symptoms
  • Ability to read and speak English
  • Ability to undergo magnetic resonance imaging (e.g., not claustrophobic, and do not have metal implants, or hip or knee replacements)

  • Participants who develop cognitive and motor problems from medical conditions can continue in the study but are excluded from tests in which the medical condition is excluded.
  • Genetic disease such as sickle cell anemnia, hemochromatosis (iron overload), cystic fibrosis, or Ehlers-Danlos syndrome (connective tissue disorder)
  • Autoimmune diseases such as Hashimoto's thyroiditis, myasthenia gravis, or rheumatoid arthritis
  • Cognitive impairment or dementia (MMSE <26 or Blessed Mental >3)
  • History of cardiovascular disease or cerebrovascular disease, including angina requiring treatment, myocardial infarction, congestive heart failure, uncontrolled hypertension, pacemaker, stroke or transient ischemic attack
  • History of diabetes requiring medical treatment other than diet and exercise, with fasting glucose level <126 mg/dL
  • Cancer within the past 10 years, except for locally limited basal cell cancer
  • Clinically significant hormonal dysfunction; mild hypothyroidism in participants over age 60 is allowed
  • History of neurological disease or birth defect (other than minor anatomical abnormalities, which do not affect physical and/or cognitive function)
  • History of kidney or liver disease; history of severe gastrointestinal disease requiring chronic treatment (GERD, Crohn's disease, ulcerative colitis); history of severe pulmonary disease (COPD or asthma requiring continuous medication use); muscle-skeletal conditions due to diseases or traumas that cause pathological weakness and/or chronic pain
  • History of severe psychiatric conditions associated with behavioral problems or requiring chronic medical treatment
  • Medical condition that requires continuous, long-term treatment with antibiotics, corticosteroids, immunosuppressors, H2 blockers and/or proton pump inhibitors, or pain medications, or that requires the use of chronic anticoagulant medication such as warfarin, heparin, or antiplatelet agents other than low-dose aspirin
  • Important sensory deficits that preclude participating in standard neuropsychological tests or providing informed consent
  • Pregnant or nursing
  • Current smoking or smoking within the past 3 months
  • History of allergy to acid-citrate-dextrose (ACD) anticoagulant or active bleeding disorder such as hemophilia
  • History of seizures within the last 3 months
  • History of Lyme disease, unless 6 weeks after treatment and no new symptoms
  • HIV virus infection; hepatitis B or C; active syphilis, gonorrhea or tuberculosis requiring treatment
  • Laboratory results outside ranges determined by study leaders; positive urine drug screen (unless taking prescribed medication)

Based on emerging evidence, investigators hypothesize that slowing aging should delay the onset of chronic diseases that affect older adults and improve longevity and quality of life. To conduct a comprehensive analysis, GESTALT investigators will evaluate genetic factors as well as non-genetic biomarkers, which reflect the interaction between genetic variation and environmental/behavioral factors.

For this study, participants will take part in a medical history, physical exam, blood and urine tests, and heart tests. They will have a 2-day baseline visit, followed by visits every 2 years for up to 10 years, during which they will repeat screening procedures, including balance and walking tests, leg and grip strength tests, health and mental state questions, and memory and problem-solving tests. Visits may also include magnetic resonance imaging scans, a diabetes test, and removal of a small amount of muscle tissue and/or skin.

They will also undergo cytapheresis to collect peripheral blood mononuclear cells (PBMCs), a type of blood cell important to the immune system, for biomarker analysis. In this procedure, blood is removed through a needle in the vein of one arm and run through a machine. The blood is returned through a needle in a vein of the other arm.

The data collected in PBMCs will be compared to biomarker data obtained from muscle and skin biopsies to understand and compare biomarkers found in blood to those found in human tissues. Finally, investigators will assess the relationship of blood biomarkers to physiological measures that typically change with aging, including measures of body composition, hormones and inflammatory markers, and neurological function.

Name City State Zip Status Primary Contact
National Institute of Aging, Clinical Research Unit
Baltimore Maryland 21224 Recruiting NIA Studies Recruitment
410-350-3941
niastudiesrecruitment@mail.nih.gov

National Institute on Aging (NIA)

Name Role Affiliation
Luigi Ferrucci, MD Principal Investigator National Institute on Aging (NIA)

Name Phone Email
Linda Zukley, PhD 410-350-3983 zukleylm@mail.nih.gov

NCT02339012

The Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)